Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Phase 1 Safety and Tolerability Study of REGN9533 in Healthy Adults.

This clinical trial is an early-stage study, meaning it's the very first time a new medicine, called REGN9533, will be given to people. Researchers are looking for healthy adult volunteers to take part. The main purpose is to carefully check if the new medicine is safe and if people can take it without too many side effects. They also want to understand how the medicine works inside the body. This kind of study helps scientists learn important information about new treatments before they can be tested in larger groups of people with specific illnesses. Your participation would help advance medical science, even though this particular study is not designed to treat a disease.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

Start

18 Feb 2025

Healthy Volunteers

What is this study about?

Imagine a new jigsaw puzzle piece that scientists think might fit into the human body to help fix something. Before they can try that piece in someone who is unwell, they first need to make sure the piece itself is safe and doesn't cause any unexpected problems. That's exactly what this study, titled a 'Phase 1' study, aims to do with a new potential medicine called REGN9533.

In this study, researchers are inviting healthy adults like you to help them. They are not trying to treat any illness you might have. Instead, they want to give this new medicine to a small group of healthy people for the very first time. By doing this, they can carefully watch and learn how the medicine acts in the human body. They will be looking for any signs that it might cause side effects, even minor ones, and how well the body tolerates it.

This early research is a crucial step in developing any new medicine. The information gathered here about safety and how the body handles REGN9533 will decide if it's safe enough to continue testing in people who might actually benefit from it in the future. Your involvement, as a healthy volunteer, is incredibly valuable for advancing medical knowledge, even though this study isn't designed to improve your own health.

Key takeaways

This is a first-time test of a new medicine in people.
It's open to healthy adults aged 18 and over, both men and women.
The main goal is to check how safe the medicine is and how the body handles it.
Your participation helps advance future medical treatments.
There are no direct personal health benefits expected.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adults to take part. This means you should generally feel well and not have any serious ongoing health problems.

To be considered, you need to be at least 18 years old. There is no upper age limit for joining this study. Both men and women are welcome to take part.

The research team will carry out some health checks to make sure you are in good general health and that it's safe for you to take part in the study. These checks will help them confirm you meet all the necessary requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you generally healthy and feel well?
Are you 18 years old or older?
Are you available for multiple clinic visits?
Do you understand this is not a treatment for an illness?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the clinic over a set period. During these visits, you would receive the study medicine, REGN9533. The healthcare team would carefully monitor you after you receive the medicine, likely taking blood samples, checking your pulse and blood pressure, and asking about how you feel to look for any side effects. You might need to stay at the clinic for some of these visits. After you've had the medicine, there will be follow-up appointments to continue checking your health. The total time you would be involved in the study, from your first visit to your final check-up, will be explained in detail by the study team.

Potential risks and benefits

As this is the first time REGN9533 is being tested in humans, there are potential unknown risks, and you might experience side effects. The study team will carefully monitor you for these. There are no direct personal health benefits expected for you from taking part, as this study is for healthy volunteers and not designed to treat an illness. However, your participation is very important to help medical science learn about this new medicine, which could eventually help others. Remember, you can decide to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What does 'Phase 1' mean?

Phase 1 means this is the very first time a new medicine is being given to people, usually healthy volunteers, to check its safety and how the body handles it.

Will this medicine treat any illness I have?

No, this study is for healthy volunteers and is not designed to treat any existing illnesses. Its purpose is to gather safety information.

What kind of tests will I have?

You will likely have health checks, blood tests, and vital sign measurements (like blood pressure and pulse) to monitor your health and how you react to the medicine.

Do I have to stay in the clinic?

Some parts of the study might require you to stay at the clinic for a period of observation after receiving the medicine.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any point, and you don't have to give a reason. Your decision will not affect your future medical care.